NCT05174273

Neurocognitive Effects of FMT in MDD Patients With and Without IBS

Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Valerie Taylor · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2/3 open-label controlled trial (CT) in which adults with Major Depressive Disorder (MDD) and adults who have MDD plus comorbid Inflammatory Bowel Syndrome (IBS) will be assigned to either receive oral Fecal Microbiota Transplantation (FMT) or to continue with the treatment they are currently receiving in a Treatment As Usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group. The primary goals of this study are to determine effectiveness, safety and tolerability of oral FMT in adults with MDD and in MDD who have comorbid IBS. Additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with MDD and with MDD + IBS and to determine if they improve with FMT. It is known that both, individuals with MDD and those with MDD and IBS show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to FMT. Additionally, trial feasibility will be monitored via recruitment rate, study visits adherence and participant retention to inform future trial scalability."

Conditions

• Major Depressive Disorder
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	FMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut.

Timeline

• Start date: 2022-04-06
• Primary completion: 2024-10-21
• Completion: 2026-10-21
• First posted: 2021-12-30
• Last updated: 2026-03-19

Locations

1 site across 1 country: Canada